NCT02700685已完成3 期
Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Nina Hermans
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Summed ADHD score of the ADHD-Rating Scale as rated by teachers
研究概览
简要总结
This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is between 6-12 years old (both inclusive).
- •The patient satisfies the DSM-IV criteria for ADHD or ADD.
- •The patient has a responsible caregiver who is able to provide information about the patient's functional status.
- •Written informed consent is obtained from the patient and the legally accepted representative.
排除标准
- •The patient does satisfy the DSM-IV for autism spectrum disorder.
- •The patient does have situational hyperactivity, pervasive developmental disorders, schizophrenia, other psychotic disorders such as mood or anxiety disorder, personality disorder as unsocial behaviour, personality change due to a general medical condition, mental retardation (IQ < 70), understimulating environments, conduct disorder, chorea and other dyskinesias. The patient does not have tics or Tourette's syndrome, or personal or family history of psychotic disorder, bipolar illness, depression, or suicide attempt.
- •The patient does have any chronic medical disorder (diabetes, epilepsy or other seizure disorder, autoimmune disorder, gastrointestinal disorder, renal or cardiovascular disorders, etc.) or acute inflammatory disease. The patient does not have glaucoma, heart disease, heart rhythm disorder, high blood pressure, or peripheral vascular disease such as Raynaud's syndrome.
- •The patient did use any of these medications during the 3 months before entering the study: clonidine, guanethidine, blood thinners (e.g. warfarin or Coumadin), antidepressants (e.g. amitriptyline, citalopram, doxepin, fluoxetine, nortriptyline, paroxetine, sertraline), cold or allergy medicine that contains a decongestant, medications to treat high or low blood pressure, seizure medicine (e.g. phenobarbital, phenytoin, primidone), or diet pills.
- •The patient did take MAO inhibitor (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline or tranylcypromine) in the past 14 days.
- •The patient has any other contraindication for the use of methylphenidate.
- •The patient did use vitamin/mineral/herbal/omega-3 supplements or other any medication (psychoactive medication, antibiotics, anti-inflammatory drugs, melatonin, etc.) > 1 week during the 3 months before inclusion.
研究组 & 干预措施
Pycnogenol
Experimental
Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.
Subjects < 30 kg body weight: 20 mg Pycnogenol/day Subjects >= 30 kg body weight: 40 mg Pycnogenol/day
干预措施: Pycnogenol (Dietary Supplement)
Placebo
Placebo Comparator
Placebo treatment (identical capsules containing excipients only)
干预措施: Placebo (Other)
Methylphenidate
Active Comparator
Standard pharmaceutical treatment for ADHD, slow release. Subjects < 30 kg body weight: 20 mg methylphenidate once per day Subjects >= 30 kg body weight: 30 mg methylphenidate once per day
干预措施: Methylphenidate (Drug)
结局指标
主要结局
Summed ADHD score of the ADHD-Rating Scale as rated by teachers
时间窗: 10 weeks
次要结局
- Scores on ADHD subscales of the ADHD-RS as rated by parents and teachers - hyperactivity, impulsivity and inattention(5 & 10 weeks)
- Social behavior problems subscale of the SEQ, as rated by parents and teachers(10 weeks)
- Anxiety subscale of the SEQ, as rated by parents and teachers(10 weeks)
- Urinary 8-OHdG level(10 weeks)
- Plasma antibody levels(10 weeks)
- Gene expression(10 weeks)
- Serum neuropeptide Y(10 weeks)
- Serum zinc(10 weeks)
- Summed ADHD score of the ADHD-Rating Scale as rated by teachers(5 weeks)
- Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents and teachers(10 weeks)
- Scores on ADHD subscales of the SEQ as rated by parents and teachers - hyperactivity, impulsivity and inattention(5 & 10 weeks)
- Percentage of responders (ADHD-RS) as rated by parents and teachers(5 & 10 weeks)
- Summed ADHD score of the ADHD-Rating Scale as rated by parents(5 weeks, 10 weeks)
- Percentage of responders (SEQ) as rated by parents and teachers(5 & 10 weeks)
- Physical and sleep complaints score as measured by the Physical Complaints Questionnaire (PCQ)(5 & 10 weeks)
- Erythrocyte glutathione (GSH) level(10 weeks)
- Plasma cytokine levels(10 weeks)
- Intestinal microbial composition(10 weeks)
- Intervention acceptability(10 weeks)
- Long-term follow up(6 months)
- Urinary catecholamines(10 weeks)
- Plasma lipid-soluble vitamins(10 weeks)
研究者
研究点 (3)
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